Sr Director CDOS Process Owner - Clinical Trial Foundations

Primary Responsibilities

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Business Process Ownership

• Leverages drug development expertise, and knowledge of internal and external requirements, industry best practices and benchmarks, inspection and audit findings, new capabilities, and advances in technology including information flow to define operational strategy and design processes that meet overall clinical development performance objectives.
• Maintains an integrated holistic view across CDOS processes ensuring cohesion and alignment.
• Establishes deep knowledge and clear understanding of assigned processes including clarity of process inputs, outputs and dependencies (e.g., connected processes, data standards, information flow implications, etc), and role accountability for critical steps and decisions.
• Drives opportunities to automate and streamline processes as new systems and technologies are adopted.
• Leads cross-functional project teams through development of process maps, process documentation (e.g. quality system documents, etc), and personnel qualification strategies.
• Establishes qualification requirements for those individuals within functions and teams who will execute processes.
• Establishes process controls (i.e., key measures for risk, quality defects, speed and cost) by which each process will be assessed.
• Defines and manages the continuous improvement agenda for the end-to-end processes and ensures compliance within a continually changing regulatory and industry landscape.
• Communicates to governance bodies on process performance and any remediation/change efforts.
• Collaborates with other Process Owners, functional leaders, subject matter experts (SMEs), Quality, Compliance and Legal to define applicable compliance and business requirements to design efficient and compliant processes.
• Partner with CDOS team members, line management and subject matter experts (SMEs) to ensure process execution expectations are clear, collect process performance feedback, and make sure the process runs smoothly and efficiently.
• Support inspection readiness with teams, partner with quality and functional leaders on responses to audit and inspection findings.

Expertise and Employee Development

• Engage in coaching and training, as needed, to ensure the effective implementation and execution of the processes they own.
• Effectively engage in the external environment to ensure a continuous state of awareness regarding current and evolving trends in relevant topic areas.
• Effectively incorporate learnings into training and development and process improvement initiatives.
• Influence industry through participation in cross-industry initiatives and by providing feedback on draft guidance.

Project Leadership

• Related to Area of Process/System Ownership: Identify and lead complex, large-scale, cross-functional projects that are within or synergistic with their scope of process ownership and critical to the business.
• Authoritatively represent assigned processes within broader change or transformation initiatives.
• System ownership as assigned/needed for systems supporting their processes.